For a complete discussion of FSMA section 103(c) and on-farm activities, please refer to section VIII.B through VIII.D of the document for the proposed rule for preventive controls for human food (78 FR 3646).
B. Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition
As discussed in section VII.A, section 103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover "(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership."
As used in section 103(c)(1) of FSMA, the term "risk analysis" is ambiguous. One interpretation is that the common meaning of the term is intended--a simple evaluation of whether activity/animal food combinations are likely to result in the consumer (animals in relation to food for animals) becoming ill. Another interpretation is that the "risk analysis" should be consistent with the formal definition and related terms used by Codex with respect to food safety (Ref. 34):
* Risk is a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.
* Risk analysis is a process consisting of three components: risk assessment, risk management and risk communication.
* Risk assessment is a scientifically-based process consisting of hazard identification, hazard characterization, exposure assessment, and risk characterization.
* Risk management is the process, distinct from risk assessment, of weighing policy alternatives, in consultation with interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.
* Risk communication is the interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.
Because section 103(c)(1)(C) of FSMA calls for a science-based risk analysis, the Agency is applying the Codex definitions to the extent possible. It is not clear whether the requirement of section 103(c)(1)(C) of FSMA to conduct a science-based risk analysis was intended to encompass all three components of risk analysis. Section 103(c)(1)(D) of FSMA requires the Secretary to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in section 418 of the FD&C Act, including hazard analysis and preventive controls, and the mandatory inspection frequency of section 421, or to modify those requirements for facilities engaged in on-farm manufacturing, processing, packing, or holding activities determined to be low risk involving animal foods determined to be low risk. Thus, section 103(c)(1)(D) of FSMA is focused on ensuring that the Agency's risk management decisions with respect to exempting or modifying requirements applicable to low-risk on-farm activity/animal food combinations under sections 418 and 421 are science-based, as determined by an analysis of the risk of specific types of on-farm activity/animal food combinations required by section 103(c)(1)(C). The Agency therefore tentatively concludes that the analysis required by section 103(c)(1)(C) should be limited to an assessment of the risk of specific types of on-farm activity/animal food combinations for the purposes of making the risk management decisions required by section 103(c)(1)(D). The risk communication component of the risk analysis is accomplished through the discussion of that assessment in this document, the opportunities for public comment (on the risk assessment and on this proposed rule), and the Agency's evaluation of, and response to, comments in a final rule.
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